Bio Pharma Dive
SEPTEMBER 29, 2022
Expectations are now higher for amyloid-clearing drugs from Eli Lilly and Roche after lecanemab showed it can slow the disease’s progression in a large Phase 3 clinical trial.
AuroBlog - Aurous Healthcare Clinical Trials blog
SEPTEMBER 29, 2022
Monitoring the status of critically-ill patients in hospital is an essential task often complicated by the need to make tough, high-stake decisions under pressure. In intensive care especially, seconds count. According to a new study, algorithms could soon fill the role instead. Researchers propose software could be trained to accurately and reliably spot changes in […].
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Bio Pharma Dive
SEPTEMBER 29, 2022
The planned split is a major shakeup for the world’s largest drugmaker and one of the most familiar corporate brands. The new company will sell well-known products like Tylenol and Band-Aids.
Pharmaceutical Technology
SEPTEMBER 29, 2022
The European Medicines Agency (EMA) has accepted Moderna ’s submission seeking a variation to the Conditional Marketing Authorization (CMA) for assessing a 50µg dose of the Omicron-based bivalent Covid-19 booster candidate, mRNA-1273.222, for adults aged 12 years and above. The mRNA-1273.222 vaccine comprises 25µg doses of mRNA-1273 (Spikevax) and a vaccine candidate against the BA.4/BA.5 subvariants of Omicron.
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Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud
Bio Pharma Dive
SEPTEMBER 29, 2022
The startup, which emerged Wednesday with $37 million in funding, is the latest in a growing list of companies trying to top Bristol Myers’ TYK2 inhibitor Sotyktu.
Pharmaceutical Technology
SEPTEMBER 29, 2022
Indian company Torrent Pharmaceuticals has signed a definitive agreement for the complete acquisition of Curatio Healthcare for $245.16m (Rs20bn). The deal comprises cash and cash equivalents worth $14m (Rs1.15bn) in the acquired business representing an enterprise value of $231m (Rs18.85bn). The latest takeover is anticipated to boost the presence of Torrent in the dermatology segment.
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Pharmaceutical Technology
SEPTEMBER 29, 2022
Scribe Therapeutics and Sanofi have signed a strategic partnership to expedite the development of breakthrough clustered regularly interspaced short palindromic repeats (CRISPR)-based cell therapies for cancer. The alliance will leverage the CRISPR genome editing technologies of Scribe to facilitate in genetic modification of new natural killer (NK) cell therapeutics for cancer.
Rethinking Clinical Trials
SEPTEMBER 29, 2022
In this Friday’s PCT Grand Rounds, Marianne Chase of Massachusetts General Hospital and Dr. Jörg Goldhahn of ETH Zurich will present “CTTI’s Digital Health Trials Hub: Multi-Stakeholder Resources to Conduct Effective Digital Health Trials.” The Grand Rounds session will be held on Friday, September 30, 2022, at 1:00 pm eastern. Chase is senior director for clinical trial operations as Mass General’s Neurological Clinical Research Institute.
STAT News
SEPTEMBER 29, 2022
A clinical trial of one or perhaps two experimental vaccines designed to protect against the Ebola Sudan virus could soon begin in Uganda, as long as the country agrees to allow the research to take place, an official of the World Health Organization said Wednesday. The trial could get underway within a couple of weeks and definitely before the end of October, said Ana Maria Henao-Restrepo, who heads WHO’s R&D Blueprint effort to develop drugs, diagnostics, and vaccines to respon
NPR Health - Shots
SEPTEMBER 29, 2022
Researchers say diseases that spread between humans and animals will become increasingly commonplace as human expansion into previously uninhabited areas intensifies.
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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
STAT News
SEPTEMBER 29, 2022
The news Tuesday night that a clinical trial of an experimental Alzheimer’s therapy had succeeded hit like a blast — at last, a rare win in a disease devastating nearly 6 million Americans and countless more caregivers. The trumpeting from the companies Eisai and Biogen relied on data that showed that people receiving the therapy, lecanemab, saw a slower decline versus those on a placebo.
NPR Health - Shots
SEPTEMBER 29, 2022
Russell Cook expected a quick, inexpensive visit to an urgent care center for his daughter after a car wreck. She wasn't badly hurt, but they were sent to an emergency room — for a much larger bill.
STAT News
SEPTEMBER 29, 2022
News of the first clearly successful clinical trial for a new Alzheimer’s disease treatment in two decades has brought hope, scrutiny, and skepticism to a field accustomed to disappointment. Whether that treatment is a meaningful advance or another false dawn depends on scientific details yet to be presented and corporate decisions still to be made.
AuroBlog - Aurous Healthcare Clinical Trials blog
SEPTEMBER 29, 2022
The members of the All Kerala Chemists and Druggists Association (AKCDA) in Thiruvananthapuram district will take a solemn oath along with students of pharmaceutical sciences and their teachers on September 25, as part of the institution’s World Pharmacist Day celebration. Over 500 chemists will join the students and teachers of the John Enoch College of […].
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When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.
STAT News
SEPTEMBER 29, 2022
For people living with type 1 diabetes, it pays to be good at math. Keeping blood glucose in a healthy range requires a constant stream of calculations: counting the carbs in each meal, and then finding the right dose of insulin to balance them out. But new clinical trial results from an automated insulin delivery system from Beta Bionics suggest that computation can be reliably outsourced to a machine — potentially putting better blood glucose control in the hands of more patients.
pharmaphorum
SEPTEMBER 29, 2022
Biogen and Eisai have resurrected hopes that amyloid-targeting drugs could have a benefit in Alzheimer’s disease with a claim that their new drug lecanemab showed a “highly statistically significant” reduction in clinical decline in a phase 3 trial. The highly-anticipated readout from the Clarity AD has shown that lecanemab met primary and secondary endpoints in patients with early-stage Alzheimer’s, said the two companies in a joint statement – although for now only the
STAT News
SEPTEMBER 29, 2022
The Covid-19 pandemic set back many of the global health goals for 2030. One of the most feasible to recover is the target of eliminating human deaths from rabies , thanks to an effective, inexpensive vaccine for dogs. Yet this ambition, backed by the United Nations , is in jeopardy because public health budgets for controlling the disease are often directed toward treatment for people exposed to it, even though the greatest public health risk comes from infected dogs.
pharmaphorum
SEPTEMBER 29, 2022
In Part 1 of this series, general wellness devices and mobile medical applications (MMAs) will be considered. Part 2 of this series will be devoted to clinical decision support (CDS) software. The FDA’s General Approach to Regulating mHealth Products. Although mHealth has been gaining in popularity for at least the past decade, before commercializing their mHealth products, developers must determine whether the product is subject to U.S.
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This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.
STAT News
SEPTEMBER 29, 2022
Institutional declarations of support for Black lives were ubiquitous in the aftermath of the murder of George Floyd. The radical, transformative change demanded by hundreds of thousands of protestors across the country, however, has not been realized. Health systems can and must help move the country in that direction. Addressing immediate social needs, such as food insecurity, housing, or access to health care, as some health systems are now doing, is important.
NPR Health - Shots
SEPTEMBER 29, 2022
The TV news host, who memorably was tested for colon cancer on the Today show, wrote on her website that she's had surgery and radiation treatment. "Please get your annual mammogram," she said.
STAT News
SEPTEMBER 29, 2022
This is part of a series of snapshots from post-Roe America. I t started as a joke. Jen was early in her first pregnancy, sitting with her husband after lunch. You know those gimmicky websites, he was saying, where you can name a star after someone and the person gets a certificate in the mail? What if, instead, we named our child after the biggest planet in the solar system?
Pharma Times
SEPTEMBER 29, 2022
Results show reduction of clinical decline in global study of people with Alzheimer's Disease
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As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.
STAT News
SEPTEMBER 29, 2022
The Food and Drug Administration wants to update its rules for which foods can be branded “healthy.” The proposed label rule aims, in part, to address a question as old as medicine: What does it mean for a food to be healthy? It would update the “healthy” label guidelines from 1994 to match up-to-date nutrition research — a notoriously messy and heavily debated field.
Pharma Times
SEPTEMBER 29, 2022
Positive results in COVID-19 therapy phase 3 trials show effectiveness against five symptoms
STAT News
SEPTEMBER 29, 2022
The announcement Tuesday night from Eisai and Biogen that their experimental medicine, lecanemab, reduced Alzheimer’s patients’ decline as measured by a clinical questionnaire is one of the biggest — and potentially happiest — shocks in the recent history of medicine. It’s a shock because Biogen had so bungled the launch of their previous Alzheimer’s drug, Aduhelm, with failed clinical trials, a tortuous path to approval , and a wholesale rejection by Me
Pharmaceutical Commerce
SEPTEMBER 29, 2022
Former head of data management and knowledge management at Germany’s National Center for Diabetes Research, Dr. Alexander Jarasch outlines his ideas around the future of AI and data management in the pharma and healthcare space.
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Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.
STAT News
SEPTEMBER 29, 2022
Editor’s note: A livestream of the conversation will be embedded below at 1 p.m. ET. Despite all of their promise, newer medicines, especially those based on advanced technologies, have been met with unprecedented challenges in scaling up manufacturing, quality control, and commercial launch.
pharmaphorum
SEPTEMBER 29, 2022
Sanofi and Regeneron have claimed the first approval in the US for a drug for prurigo nodularis, after the FDA gave a green light to Dupixent as a treatment for adults with the rare skin disease following a priority review. There are about 75,000 adults in the US living with prurigo nodularis who are in desperate need of new treatment options, according to the two drugmakers.
STAT News
SEPTEMBER 29, 2022
What’s a hallucinogen without the hallucinations? Perhaps a potent and fast-acting antidepressant, according to a new study based on virtual drug screening. Psychedelic drugs are now widely understood to have striking antidepressant effects , so a group of computational biologists sought to determine whether any new, LSD-adjacent molecules might have other medicinal powers.
NPR Health - Shots
SEPTEMBER 29, 2022
Scientists have identified a drug that appears to produce the antidepressant effects of LSD without the psychedelic side effects — at least in mice.
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The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.
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